LEVEKEP (Micro Labs Pty Ltd)
Product name
LEVEKEP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
114 (255 working days)
Active ingredients
Levetiracetam
Registration type
New generic medicine
Indication
LEVETIRACETAM B&B, LEVETIRACETAM MLABS, MICROCETAM, LEVECETAM, LEVETERICETAM WP concentrated injection for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.
LEVETIRACETAM B&B, LEVETIRACETAM MLABS, MICROCETAM, LEVECETAM, LEVETERICETAM WP concentrated injection for IV infusion is indicated for:
- Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation.
- Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.
- Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME).
- Add on therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).